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FDA 510(k)

FUTURA GLASS IONOMER SILVER REINFORCED

K-Number: K991974 · 1999-09-17

ApplicantAb Ardent
Decision Date1999-09-17
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FUTURA GLASS IONOMER SILVER REINFORCED is the device name listed in this FDA 510(k) record. The listed applicant is Ab Ardent. It received FDA 510(k) clearance on 1999-09-17 under 510(k) number K991974. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUTURA GLASS IONOMER SILVER REINFORCED?

FUTURA GLASS IONOMER SILVER REINFORCED is a medical device that received FDA 510(k) clearance on 1999-09-17. The listed applicant is Ab Ardent. The 510(k) number is K991974.

When did FUTURA GLASS IONOMER SILVER REINFORCED receive FDA 510(k) clearance?

FUTURA GLASS IONOMER SILVER REINFORCED received FDA 510(k) clearance on 1999-09-17, under 510(k) number K991974.

Who is the listed applicant for FUTURA GLASS IONOMER SILVER REINFORCED?

The FDA 510(k) record lists Ab Ardent as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUTURA GLASS IONOMER SILVER REINFORCED?

The FDA product code for FUTURA GLASS IONOMER SILVER REINFORCED is EMA.

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Other records listing Ab Ardent as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131753MERIDIANK040465LATIT FLOWK022971MICROHYBRID 11K022972MICROFILL 13K022973ADHESIVE 14K022975ETCHING 15

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Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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